Kornimate/medical-research-clean huggingface dataset:
safety study of viaskin® peanut patch in peanut-allergic children 1 through 3 years of age (comfort toddlers)

Conditions: Allergy; Peanut Allergy

Summary: the primary objective of this study is to assess the 6-month safety of dbv712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

this is a phase 3 randomized double-blind, placebo-controlled (dbpc) study of 6-months duration to assess the safety of dbv712 250 mcg in subjects 1 through 3 years of age with peanut allergy. participants who complete the 6-month dbpc period will be eligible to enter an optional 18-month open-label extension (ole). the overall maximum study duration for each participant will be approximately 112 weeks: screening period of 6-weeks, dbpc treatment period of 26-weeks, open-label period of 78-weeks and follow-up period of 2-weeks. for participation eligibility, please refer to eligibility criteria section. randomization of eligible participants will occur in a 3:1 ratio to dbv712 250 mcg (active treatment) or placebo, respectively.

Eligibility criteria:
key inclusion criteria: * aged 1 through 3 years at visit 1 (screening). * physician-diagnosed peanut allergy and following a strict peanut-free diet * peanut-specific ige \> 0.7 kua/l. * a positive peanut spt with the largest wheal diameter of ≥ 6 mm at visit 1 (screening). * an ed ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (dbpcfc). key exclusion criteria: * peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut. * severe generalized dermatologic disease involving the proposed treatment application area (interscapular region). * current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy). * history of any immunotherapy for peanut allergy, including epicutaneous immunotherapy (epit), oral immunotherapy (oit), sublingual immunotherapy (slit). * treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to visit 1. * uncontrolled persistent asthma.

Keywords: peanut hypersensitivity epicutaneous immunotherapy (epit) epicutaneous immunotherapy viaskin nut and peanut hypersensitivity food hypersensitivity peanut allergy food allergy nut and peanut allergy safety study
evaluation of the safety and usability of the m3t fertigo system and its calibration

Conditions: Infertility, Female

Summary: we have developed a new minimally invasive system for endometrial dating, that allows the physician to monitor, capture, project and analyze the actual morphology and maturity of the endometrial surface, at any given time. a time series of such indications provides an assessment regarding the pace of development by which the endometrium is maturing during a relevant cycle. fertigo®'s method for endometrial dating has been validated in swine and ex-vivo human samples, where image analysis of tissues has been compared with traditional endometrial dating techniques. the comparison yielded calibration means and correlation between fertigo®'s dating and the traditional dating methods. thus, m3t fertigo®'s system is designed to enable the determination of the actual physiological cycle date, in good correlation with the indirect (endometrial thickness and hormones level) and delayed known methods (histopathology). to this end, a high quality, low magnification (x2-x4) image of the endometrium surface should be acquired, stored and analyzed. this trial will evaluate, on the one hand, the safety and usability of the fertigo® device and, on the other hand, calibrate it by evaluating image quality. both safety and usability will be measured through questionnaires answered by the participants (adverse events and satisfaction) and by the physicians (satisfaction), respectively, considering the introduction of the device, its use, and its removal.


Eligibility criteria:
inclusion criteria: 1. healthy women 2. age: 18 - 40, both inclusive 3. regular menstrual cycles exclusion criteria: 1. simultaneous participation in another clinical study that, at researcher's criteria, could interfere with the results of this study 2. current pregnancy 3. women with known existing endometrial pathology 4. women with known oligo-ovulation or un-ovulation. 5. women who were diagnosed with endometriosis or adenomyosis 6. women with medical history of malignant tumors in their reproductive system 7. women with iud in place 8. women menstruating on the day of the procedure 9. women who have signs and symptoms of pid 10. women who currently use any hormonal medications.
a study for patients with non-hodgkin's lymphomas

Conditions: T-Cell Lymphoma; B-Cell Lymphoma

Summary: in this study, all patients will get investigational drug. there will be no comparator drug. this study will evaluate three tumor types: t-cell lymphoma, indolent b-cell lymphoma, and aggressive b-cell lymphoma. each tumor type will include several tumor subtypes: * t-cell lymphoma: peripheral and cutaneous t-cell lymphoma (ptcl, ctcl) * indolent b-cell lymphoma: small lymphocytic lymphoma, follicular lymphoma (gr 1 or 2) and marginal zone lymphoma * aggressive b-cell lymphoma: primary cns lymphoma, follicular lymphoma (gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.


Eligibility criteria:
inclusion criteria: * have measurable lesions * have recovered from prior chemotherapies * have an estimated life expectancy of at least 12 weeks * hepatic: total bilirubin less than or equal to 1.5 xuln; atl/ast less than or equal to 2.0 x uln (less than 5x if liver metastases are present) * renal: serum creatinine less than or equal to 1.5xuln * adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /liter (l) criteria: * have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). * anti-lymphoma therapy within the past 3 weeks * unable to swallow tablets * unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment
nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin in the neoadjuvant therapy for breast cancer

Conditions: Breast Cancer; Triple-negative Breast Cancer; Nab-paclitaxel

Summary: this is a multicenter, open, randomized, comparison study. triple-negative breast cancer (tnbc) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (er) and the progesterone receptor (pr) and do not over express her2. neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. the purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery. the purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application. the total number of patients to be included in this study is 520 patients.


Eligibility criteria:
inclusion criteria: 1. females with age between 18 to 70 years old; 2. histologically confirmed primary invasive breast cancer; 3. histologically confirmed triple negative breast cancer; 4. patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm. 5. blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained. 6. have at least one measurable lesion as per the recist criteria (version 1.1); 7. eastern cooperative oncology group (ecog) performance status less than or equal to one; 8. lvef≥55%； 9. bone marrow function：neutrophils (≥1.5×10\^9/l), platelets (≥100×10\^9/l), hemoglobin (≥90 g/l); 10. renal and hepatic function: serum creatinine≤ 1.5×institutional upper limit of normal (uln); ast and alt ≤ 2.5 × uln; total bilirubin≤1.5×uln, or patients with gilbert's syndrome ≤ 2.5 × uln; 11. patients had good compliance with the planned treatment, understood the research process and written informed consent. exclusion criteria: 1. previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy; 2. patients with heart disease above grade ii (including grade ii) identified by new york heart association (nyha) scores; 3. patients with severe systemic infection or other serious diseases; 4. patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants; 5. patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; 6. pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial; 7. participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given; 8. the researchers considered the patients who were not suitable for enrollment.

Keywords: triple-negative breast cancer nab-paclitaxel carboplatin epirubicin
the effect of pre-operative single dose antibiotic prophylaxis on the post-operative implant success

Conditions: Tooth Loss

Summary: there is no consensus on antibiotic prophylaxis in dental implant applications, and its necessity is controversial. current reports on antibiotic use are insufficient. also, other than antibiotic prophylaxis, data that may affect the post-operative situation such as the patient's gender, age, smoking, duration of surgery, length of the operation field, flap design have not been evaluated comprehensively. this study aims to evaluate post-operative complications, implant success, and implant stability in 50 individuals: preoperative single dose of 2 g amoxicillin + clavulanic acid (25) and placebo (25).


Eligibility criteria:
inclusion criteria: * tooth loss exclusion criteria: * systemic disease * lactation/pregnancy

Keywords: dental implants antibiotic prophylaxis
self-screening of cardiovascular risk

Conditions: Risk Factor, Cardiovascular

Summary: the aims of this study are (1) to validate a self-screening method for cardiovascular (cv) risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) from these data, the investigators will generate personalized recommendations based on the best available evidence. the investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases.

primary prevention activities based on some admittedly blunt screening instruments such as cardiovascular (cv) risk functions must be addressed to the whole population, prioritizing certain sectors of the population. however, the main limitation of current risk screening procedures is related to the natural history of cardiovascular disease, whose expression depends on the cumulative exposure to cardiovascular risk factors throughout a person's lifetime. early prevention of cardiovascular disease is key to reduce this cumulative risk, thereby reducing the incidence of cardiovascular events. the objectives of this study are (1) to validate a self-screening method for cardiovascular risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) from these data, the investigators will generate personalized recommendations based on the best available evidence. the investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases. cardiovascular risk measured with the self-screening method will be compared with the gold standard (cardiovascular risk supervised by health professional). participants will be randomly assigned to the intervention (communication of cardiovascular risk and recommendation of personalized preventive actions) or control groups (communication of cardiovascular risk). subjects will be reexamined one year after recruitment for assessing adherence to the preventive recommendations in terms of improvement in the control of cardiovascular risk factors.

Eligibility criteria:
inclusion criteria: * understand and accept the study's procedures and sign an informed consent form * inhabitants of girona (gerona, spain) and the metropolitan area exclusion criteria: * history of cardiovascular disease * individuals with terminal disease

Keywords: cardiovascular risk cholesterol hypertension diabetes smoking preventive medicine epidemiology public health diet physical activity
assessment and follow-up of surgical treatment of hemivertebra in children

Conditions: Hemivertebra

Summary: the treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. the surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). these surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

the treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. the surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). these surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).

Eligibility criteria:
inclusion criteria: * child from 3 to 10 years old * with a vertebral malformation requiring surgery for hemivertebras exclusion criteria: * child previously operated on the spine * different procedure of a surgical resection of vertebral malformation * absence of medical follow-up * parents refusal concerning data storage

Keywords: vertebral malformation hemivertebra surgical resection sofop
maximizing the benefit of renin-angiotensin blocking drugs in diabetic renal disease.

Conditions: Diabetic Nephropathy

Summary: the angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. the hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.


Eligibility criteria:
inclusion criteria: proteinuria greater than 1 gram/day serum creatinine \< 2.6 for men, \< 2.0 for women exclusion criteria: blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months
influence of interferential current therapy in the treatment of individuals with shoulder impact syndrome: a randomized, placebo controlled clinical trial.

Conditions: Shoulder Impingement Syndrome

Summary: this project will analyze the influence of interferential current therapy in an exercise program for individuals with a unilateral impact syndrome diagnosis. to that end, volunteers of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment, positivity in at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into the following groups: exercise group, exercise + ultrasound group, exercise group + interferential current. sixteen consecutive treatment sessions will be performed, and the volunteers will be evaluated before and after, by means of the following instruments: numerical scale of evaluation of pain, shoulder pain and disability index (spadi), pain-related catastrophizing thoughts scale, being applied the numerical scale of evaluation of pain at the end of each session and one month after the end of treatment.


Eligibility criteria:
inclusion criteria: * history of anterolateral, unilateral pain in the shoulder with more than 3 months duration. * medical diagnosis, * minimal grade 4 pain by numerical scale of pain assessment, * positivity in at least 2 of 3 orthopedic tests for impact syndrome: neer, hawkins or jobe. exclusion criteria: * fibromyalgia diagnosis, * pregnancy, * numbness or tingling in the upper limb * history of shoulder trauma, other shoulder related diseases, * ruptured tendons, ligament laxity, * symptoms of numbness and / or tingling in the upper limbs, history of shoulder and / or cervical surgery * use of corticosteroid injection in the shoulder, and analgesic, anti-inflammatory or muscle relaxant use and have or have undergone physiotherapeutic treatment in the last 6 months.
a long-term extension study of riociguat in patients with symptomatic pulmonary arterial hypertension.

Conditions: Hypertension, Pulmonary

Summary: to provide riociguat therapy to eligible patients with pah originating from bayer-sponsored trials with bay63-2521/ riociguat / adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pulmonary arterial hypertension (pah) participating or having participated in the bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment. * women and men of reproductive potential must agree to use adequate contraception when sexually active. this applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug. exclusion criteria: * ongoing serious adverse event (sae) from originating study that is assessed as related to riociguat * pregnant women or breast-feeding women * any contra-indication to adempas treatment listed in the bay63-2521 / riociguat investigators's brochure * concomitant participation in another clinical study with the study drug * patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (ph-iip)
efficacy of a streamlined heart failure optimization protocol

Conditions: Heart Failure with Reduced Ejection Fraction; Chronic Heart Failure

Summary: the short trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.

the short trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial. it assesses whether an accelerated protocol leads to faster optimization and a greater degree of optimization.

Eligibility criteria:
inclusion criteria: * ejection fraction of less than or equal to 40% * increased nt-probnp level: * ≥ 600 pg per milliliter or * ≥400 pg per milliliter if they had been hospitalized for heart failure within the previous 12 months or * patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an nt-pro bnp level of at least 900 pg per milliliter, regardless of their history of hospitalization for heart failure or * recent heart failure admission or clinical diagnosis of heart failure. * patients who are either naïve to or taking no more than 25% target doses of beta blockers or acei or arb before starting the trial. exclusion criteria: * systolic bp of less than 100 mmhg on 2 consecutive measurements * estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73m2 * type 1 diabetes mellitus * cognitive impairment that in the opinion of the investigator may lead the patient to be unable to understand and/or comply with the study medications, procedures and/or follow-up * uncorrected primary valvular disease * active malignancy treatment at time of visit 1 * women of child-bearing potential who are not willing to use a medically accepted method of contraception that is reliable in the judgement of the investigator\* * women who are pregnant or breastfeeding * history of angioedema, or hereditary or idiopathic angioedema * severe hepatic impairment, biliary cirrhosis or cholestasis * patients who are receiving treatment with an aliskiren-containing product who have diabetes mellitus or renal impairment (egfr \<60 ml/min/1.73 m2) * highly effective methods of contraception include implants, injectables, combined oral contraceptives (the participant must have been on a stable dose for at least 3 months before entering the trial), intrauterine device, vasectomised partner, or true sexual abstinence (when this is the preferred and usual lifestyle of the patient and does not include periodic abstinence \[e.g. calendar, ovulation, symptothermal or post-ovulation methods\]). use of such methods must be maintained throughout the trial and for 7 days after the end of the trial.

Keywords: medication sequencing optimization
combined intravitreal injection of bevacizumab and fasudil versus bevacizumab alone for macular edema secondary to retinal vein occlusion in previously treated patients

Conditions: Retinal Vein Occlusion

Summary: this study is aimed to compare the effect of combined intravitreal bevacizumab and fasudil injection with bevacizumab only injection in patients with persistant macular edema secondary to ratinal vein occlusion. methods: in this study patients with retinal vein occlusion patient who had at least three or more intravitreal antivegf injection with persistence of macular edema at funduscopic examination is recruited. the eligible patients in randomized in two groups "bevacizumab" and "bavacizumab + fasudil" and in injected intravitreally for 3 times monthly. in "bevacizumab+fasudil" group patients receive two injections at each session bavacizumab and fasudil. in "bevacizumab" group patients receive only bevacizumab. the patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. baseline ancillary exams include fluorescein angiography and oct-angiography which is performed at the final exam as well. patients needing any therapeutic intervention is addressed during the 6 month follow up period.


Eligibility criteria:
inclusion criteria: * branch retinal vein or central retinal vein occlusion previous at least 3 intravitreal antivegf injection macular edema in sd-oct cmt = \>250 microns bcva equal or lesd than 20/40 exclusion criteria: * moderate or severe corneal opacity significant cataract obscuring retinal exam or oct glaucoma history of vitreoretinal surgery diabetic retinopathy macular disease (amd,erm,vmt kidney or liver disease uncontrolled or moderate or severe anemia uncontrolled hypertention